Quality Control Technician

Are you a qulaity control technicina with adequate experience in the field? This 12-month role maybe a good fit for you.

Under the supervision of the Manager, Stability, Verification & Validation (Handheld), the V&V Test Technician Level 1 supports the aspects of data acquisition for various in-house and field programs for current product support (CPS) such as Sensor Calibration, Lifetime, Proficiency Testing (post-market surveillance) and Field Performance Evaluations, as required.

• Participates in activities towards new product development (NPD) such as verification and validation activities throughout the product lifecycle management process, assay performance evaluation including stability and shelf-life of consumables and new products development, and regulatory submittal support activities for in vitro diagnostics (IVD) instruments and consumables of blood gas products.

• Tests cards in a timely and accurate manner for the purpose of product verification, product calibration, monitoring of ongoing product performance and facilitation of product or sensor calibration process improvements.

• Is familiar with operational procedures for card testing and is capable of more complex or involved versions of those procedures to determine root causes in the case of product issues.

• Regularly interacts with Research and Development, Technical Operations, and Quality Assurance personnel.

Advantages
Is driving required:
No/Non
Overtime rates will apply after hours exceed 44 hrs/ week.

Responsibilities

• Participates in daily operations of the Stability, Verification & Validation Lab, including inventory and maintenance for necessary equipment, organization of sample preparations/donors, and assists other laboratory personnel.

• Carries out timely and accurate testing of cards for design verification and validation studies, sensor calibration, lifetime, proficiency testing, and field performance evaluation of NPD and CPS projects.

• Provides detailed annotation for all test results (data acquisition activities) so that engineering analysis can proceed effectively.

• Executes sample preparation procedures and assist with management of raw material inventories to ensure card testing is reliable and uninterrupted.

• Identifies process improvements opportunities related to in-house testing programs such as sensor calibration and lifetime.

• Communicates product performance issues or idiosyncrasies discovered during testing in a timely manner.

• Supports Assay Performance Evaluation in NPD and CPS, Quality Assurance and other groups as required.

• Collaborates with team members and other stakeholders to ensure high quality completion of the team deliverables.

• Supports team members to increase team performance, resolving any impediments where applicable.

Qualifications
Required Knowledge/Skills, Education, and Experience

• Undergraduate degree in relevant scientific majors, such as Medical Laboratory Technology, Biomedical Laboratory Technology, Clinical Laboratory Technology and/or an equivalent combination of education and technical experience.

• Minimum of 1 year of industrial experience, preferably in laboratory environment.

• Demonstrated knowledge and skill in the use of data collection and analysis programs (e.g., Excel).

• Experienced in maintenance and troubleshooting of laboratory equipment.

• Attentive to details and an ability to follow both the letter and intent of written procedures.

• Willingness to speak up about issues and to provide possible solutions.

• Ability to understand all aspects pertaining to the operation of the epoc® blood analysis system and utilize that knowledge to troubleshoot issues related to sample preparations, testing protocols, process workflows and product performance.

• A strong ability to work well in a team setting and commitment to support others.

• Excellent written and verbal communication skills.

• Ability to work with blood samples on a regular basis.

Preferred Knowledge/Skills, Education, and Experience

• Experience with testing of epoc® cards.

• Experience in a regulated industry such as pharmaceuticals or medical devices.

• Demonstrated knowledge and skill in the use of Microsoft…